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Teva has reported topline P-IIa trial results assessing TEV ‘408 in adults with celiac disease on a gluten-free diet (GFD) with minimal intestinal damage; additional analyses are underway
The trial met its 1EP, showing prevention of gluten-induced intestinal damage at Wk. 8 following a single SC dose & improving Vh:Cd ratio, with least squares (LS)…
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The US FDA has accepted a BLA for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) PFS & autoinjector for SC administration
BLA was backed by analytical, PK & immunogenicity data, showing biosimilarity with the reference product. Plus, under a partnership with Teva, Alvotech is responsible for development & manufacturing of AVT80, while Teva…
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Sandoz, Sun Pharma, and Shanghai Fosun Pharma emerged as the leading generic pharmaceutical companies in 2026, with 2025 revenues of $11.08B, $6.55B, and $5.92B, respectively. Strong demand for biosimilars, continued portfolio expansion, new product launches, and broader access to affordable medicines supported growth across the leading companies
The global generics landscape continues to evolve…
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Polpharma has granted Teva exclusive rights to commercialize both IV & SC formulations of Polpharma’s proposed biosimilar to Ocrevus (ocrelizumab) for multiple sclerosis, upon regulatory approval
As per the deal, Polpharma will lead biosimilar development & manufacturing, while Teva will oversee regulatory filings & commercialization across the US, EU, Brazil, Canada, Australia, New Zealand,…
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June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC), and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology, ophthalmology, oncology, osteoporosis, and reproductive medicine.
Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.
Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.
Celltrion Seeks…
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The US FDA has received an NDA for ecopipam, a selective dopamine D1 receptor antagonist, for the treatment of pediatric Tourette syndrome
NDA was supported by the P-III trial data showing that ecopipam significantly delayed time to relapse vs PBO in pediatric Tourette syndrome pts who responded to treatment during the open-label treatment period;…
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Teva has launched Ahzantive, a biosimilar version of Eylea, in EU, with pre-filled syringe launches beginning in May 2026 in France, Germany, Spain, & the Netherlands, and additional market launches planned later in 2026
Ahzantive received EC approval in 2025 for the treatment of wet age-related macular degeneration, diabetic macular edema, visual impairment due…
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Teva has entered into a definitive agreement to acquire Emalex Biosciences, incl. its lead asset, ecopipam, expanding its neuroscience pipeline & accelerating Teva’s pivot to growth strategy
As per the deal, Teva will acquire Emalex for $700M upfront, & ~$200M in commercial milestones, plus royalties on global net sales of ecopipam, subject to regulatory approval; closing is expected in Q3’26…
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The US FDA has approved Ponlimsi, a biosimilar version of Prolia (denosumab), for all indications of the reference product
Approval was based on extensive clinical data, incl. analytical & clinical studies, which showed comparable efficacy, safety, & immunogenicity of Ponlimsi to the reference product
Additionally, Teva’s biosimilar of Xolair (omalizumab) was accepted for review…
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Teva & Blackstone Life Sciences have entered a four-year strategic funding agreement to support the continued clinical development of duvakitug
As per the deal, Blackstone will provide $400M to Teva over four years to fund duvakitug development, while Blackstone will receive potential milestone payment subject to FDA approval, & additional commercial milestones, as well…

